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European backing for Merck's Keytruda rubs salt in Bristol-Myers' wounds

Merck's Keytruda received a positive CHMP opinion just a few days after BMS executives told investors the committee would hand Opdivo a negative one. (Merck, Bristol-Myers Squibb)

Merck’s Keytruda is one step closer to extending its dominance in the all-important previously untreated lung cancer market.

On Monday, the New Jersey drugmaker said its Keytruda-chemo combo had received a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), setting it up for a go-ahead from the agency.

Merck has been waiting a long time for European regulators to greenlight the regimen, which already bears an approval in the U.S. After submitting an application to the EMA last year based on phase 2 trial results, it pulled that application once it determined that the body would need to see more data before making a decision.

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The move stirred up drama among investors, many of whom believed it was a signal that the phase 3 data weren’t looking good enough to confirm the benefit researchers saw in phase 2. But Merck shattered that notion in April at the American Association for Cancer Research annual meeting, where it rolled out results showing that the Keytruda-chemo tandem could cut patients’ risk of death by 51%.

Now, Merck will await final word on an important indication that’ll pad its lead on its immuno-oncology rivals, none of which can boast a first-line lung cancer nod on either side of the pond. That fact helped Keytruda overtake archrival Opdivo from Bristol-Myers Squibb in the sales department in the second quarter, and analysts don’t expect the drug to look back.

Meanwhile, while Opdivo showed last week that it was holding its ground in the second-line lung cancer market better than Wall Street thought it would, executives had bad news to announce, too. CEO Giovanni Caforio, M.D., told investors CHMP would be rejecting an Opdivo-Yervoy combo in front-line kidney cancer, an important new market for Opdivo where its rivals aren’t yet competing.

“We strongly disagree” with the verdict, Caforio said, adding that Bristol-Myers would “pursue a reexamination.” Even if it holds, though, executives stressed that the setback wouldn’t keep Opdivo from growing over this year and next.